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Cardiac Imaging to Predict Embolic Stroke

N/A

Recruiting

Led By Nassir Marrouche, MD

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No history of atrial fibrillation

History of congestive heart failure or a history of transient ischemic attack (TIA)/stroke without an otherwise defined stroke etiology such as large vessel or small vessel disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day1

Awards & highlights

Study Summary

This trial shows that people who have left atrial or left atrial appendage pathology are at a higher risk for embolic strokes, even if they don't have atrial fibrillation. This could help doctors identify people who are at a higher risk for strokes and help prevent them in the future.

Who is the study for?

This trial is for adults over 18 without atrial fibrillation but with a high stroke risk score (CHA2DS2VASC ≥3), type II diabetes, or history of heart failure/TIA/stroke from unknown causes. It excludes those who've had recent strokes, are allergic to MRI contrast agents, have certain implants, severe kidney disease, weigh over 300 lbs, or are pregnant/breastfeeding.Check my eligibility

What is being tested?

The study tests if advanced cardiac and brain MRI imaging can predict the risk of embolic strokes in people without atrial fibrillation by identifying specific heart abnormalities that could lead to such strokes.See study design

What are the potential side effects?

MRI procedures are generally safe but may include discomfort from lying still during the scan. Gadolinium contrast used in MRIs can cause allergic reactions or issues in patients with severe kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had atrial fibrillation.

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I have a history of heart failure or stroke with no clear cause.

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I have been diagnosed with type II diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The presence of covert embolic cerebral infarcts

Secondary outcome measures

Number of counts of embolic symptomatic infracts

Number of counts of lacunar covert infracts

Number of counts of lacunar symptomatic infracts

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patient armExperimental Treatment1 Intervention

All patients will undergo a CMR to evaluate for LA and LAA high-risk features on either a 1.5 or 3 Tesla clinical MR scanner. Gadolinium injection will be administered. Gadolinium is a contrast product that helps define areas of fibrosis in the LA. High-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 MPRAGE, 3D FLAIR, DWI, ADC, and SWI

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor

115 Previous Clinical Trials

226,382 Total Patients Enrolled

3 Trials studying Stroke

8,881 Patients Enrolled for Stroke

Nassir Marrouche, MDPrincipal InvestigatorTulane School of Medicine

6 Previous Clinical Trials

948 Total Patients Enrolled

Media Library

Stroke Clinical Trial 2023: Cardiac and Brain MRI Highlights & Side Effects. Trial Name: NCT04769310 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings to join this medical trial?

"Per the clinicaltrial.gov database, this medical research is actively recruiting patients with an initial post date of April 26th 2021 and last updated on November 21st 2022."

Answered by AI

Are there any specific criteria for eligibility to partake in this trial?

"This clinical trial is admitting 120 individuals aged 18 and up, who are suffering from atrial fibrillation. To qualify for the study, these potential participants must meet a strict set of inclusion criteria: They must be male or female; have no history of AFib; possess a CHA2DS2VASC score ≥3; and either have prior congestive heart failure experience or had an episode of transient ischemic attack (TIA) / stroke without another known cause such as large vessel or small vessel disease."

Answered by AI

How many individuals have volunteered to participate in this experiment?

"That is correct. According to clinicaltrials.gov, this medical research effort was first advertised on April 26th 2021 and has been recruiting 120 patients from a single location since then."

Answered by AI

Is the elderly population included in the criteria for this research?

"This clinical trial has specified that only persons between 18 to 120 years old are eligible. For those under the age of 18, 56 studies exist while 1,787 trials are available for individuals over 65."

Answered by AI

Recent research and studies

CirculationJournal

Heart Disease and Stroke Statistics—2016 Update

Mozaffarian, Dariush, Emelia J. Benjamin, Alan S. Go, Donna K. Arnett, Michael J. Blaha, Mary Cushman, Sandeep R. Das, et al.. 2016. “Heart Disease and Stroke Statistics—2016 Update”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000000350.

EP EuropaceJournal

Reproducibility and Accuracy of Late Gadolinium Enhancement Cardiac Magnetic Resonance Measurements for the Detection of Left Atrial Fibrosis in Patients Undergoing Atrial Fibrillation Ablation Procedures

Mărgulescu, Andrei D, Marta Nuñez-Garcia, Francisco Alarcón, Eva M Benito, Norihiro Enomoto, Jennifer Cozzari, Fredy Chipa, et al.. 2019. “Reproducibility and Accuracy of Late Gadolinium Enhancement Cardiac Magnetic Resonance Measurements for the Detection of Left Atrial Fibrosis in Patients Undergoing Atrial Fibrillation Ablation Procedures”. EP Europace. Oxford University Press (OUP). doi:10.1093/europace/euy314.

CirculationJournal

Temporal Relationship Between Subclinical Atrial Fibrillation and Embolic Events

Brambatti, Michela, Stuart J. Connolly, Michael R. Gold, Carlos A. Morillo, Alessandro Capucci, Carmine Muto, Chu P. Lau, et al.. 2014. “Temporal Relationship Between Subclinical Atrial Fibrillation and Embolic Events”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.113.007825.

Thrombosis and HaemostasisJournal